IBTS Annual Report 2007.pdf - Irish Blood Transfusion Service

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analysis, appropriate preventative and
corrective action is identified and effectively
implemented to prevent reoccurrence.
The regular monthly quality meetings in
both the Cork Centre and NBC ensure the
major non-conformances are reviewed
and communicated with a view to effecting
system improvements.
There were 1137 non-conformances raised
in the NBC during 2007, approx. 10%
were considered as major.
The Cork Centre raised 612 nonconformances,
with 19% classified as
major. Close out of non-conformances
is a QMS metric within IBTS, monitored
through monthly meetings.
The IBTS product recall system is operated
in the main on receiving post donation
information from donors, and also to
ensure that product which has flagged
positive on the bacterial screening test is
rapidly recalled.
There were 270 product recalls instigated
by the NBC, with 74% due to post donation
information received or suspected bacterial
screening test positive during the year.
Similarly with the Cork Centre, there were
97 product recalls, with 78% due to post
donation information received or suspected
bacterial screening test positive.
returned, post donation information
and suspected bacterial screening test
positive. For the Cork Centre, there were
177 product and service complaints, with
67% comprised of transfusion reactions,
defective product and donor grievance
complaints.
Eighty validation plans were raised covering
the introduction of major changes like
Orbisac technology and 150 change
control plans dealing with control of
ongoing change to equipment, software,
hardware and processes. Through a
training and development programme the
IBTS assures currency of knowledge, skill
and GMP compliance.
There was extensive training carried out
for advanced and basic users of the EQMS
system to allow transfer to the electronic
system. A number of additional QA
personnel also completed Internal Auditor
(QS) training.
The internal audit programme covered
a total of 41 individual audits. Activities
covered mobile clinics, production and
testing. There were a total of 9 external
vendor audits conducted by quality during
the year, covering suppliers of tissue, blood
bags and critical consumables.
There is a formal documented customer
complaint system within the QMS,
which captures external customer
complaints concerning products and
service. During the year, there were 966
product complaints received by the NBC
including 270 product recalls, 70% of
which comprised of DAT positive products
Annual Report 2007